The US Food and Drug Administration today approved what it says is the first bionic eye, or retinal prosthesis, that can partially restore the sight of blind individuals after surgical implantation.
Clinical trials demonstrated that totally blind individuals could safely use the device to successfully identify the position and approximate size of objects and detect movement of nearby objects and people, the FDA stated.
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Specifically the Argus II Retinal Prosthesis System includes a small video camera, transmitter mounted on a pair of eyeglasses, video processing unit (VPU) and an implanted artificial retina. The VPU transforms images from the video camera into electronic data that is wirelessly transmitted to the retinal prosthesis. The pulses travel to the optic nerve and, ultimately, to the brain, which perceives patterns of light and dark spots corresponding to the electrodes stimulated. Blind individuals can learn to interpret these visual patterns and ultimately should improve a patient's ability to perceive images and movement, the FDA stated
The systems is aimed at helping those afflicted with a disease known as retinitis pigmentosa, which is a genetic eye condition that damages the light-sensitive cells that line the retina, the FDA says. The National Institutes of Health to affect about 1 in 4,000 people in the United States. " In a healthy eye, these cells change light rays into electrical impulses and send them through the optic nerve to the area of the brain that assembles the impulses into an image. In people with retinitis pigmentosa, the light-sensitive cells slowly degenerate resulting in gradual loss of side vision and night vision, and later of central vision. The condition can lead to blindness."
The artificial retina, dubbed the Argus II Retinal Prosthesis System was developed and manufactured by Second Sight Medical Products Inc., with significant investment - over $100 million from the US Department of Energy National Laboratories, National Eye Institute at the National Institutes of Health and the National Science Foundation.
The DOE notes that other bionic eye projects are under way in the United States Germany, Japan, Ireland, Australia, Korea, China, and Belgium. "These programs pursue many different designs and surgical approaches. Some show great promise for the future, but have yet to demonstrate practicality in terms of adapting to and lasting long-term in a human eye. Thus far the projects that have progressed to clinical (human) trials are the collaborative DOE effort, a project at the now-defunct Optobionics (Chicago), and two efforts in Germany at Intelligent Medical Implants AG and Retinal Implant AG," the DOE stated.
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